This study will compare two common approaches to pain control after lumbar spinal fusion surgery. Participants will be randomly assigned to receive either standard pain medication alone or standard pain medication plus a short course of nonsteroidal anti-inflammatory drugs (NSAIDs), including intravenous ketorolac while in the hospital and oral naproxen for one week after discharge. The main goal is to determine whether taking NSAIDs after surgery affects how well the spine heals by increasing the chance of needing another surgery because the bones did not fuse properly within 2 years. The study will also evaluate pain medication use, recovery, hospital readmissions, complications, physical therapy progress, patient-reported pain and function, and overall healing. The results will help determine whether NSAIDs can be used safely as part of pain management after lumbar spinal fusion surgery while potentially reducing the need for opioid medications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
428
Intravenous ketorolac 15 mg administered every 6 hours for up to 48 hours after surgery.
Oral naproxen 500 mg administered twice daily for 7 days after hospital discharge.
Standard postoperative multimodal pain regimen used at the institution, excluding NSAIDs administered as part of the study intervention.
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Revision surgery for symptomatic lumbar spinal fusion nonunion
The proportion of participants who undergo revision lumbar fusion surgery for symptomatic nonunion (pseudarthrosis), as determined by the treating spine surgeon based on clinical evaluation and imaging findings.
Time frame: Up to 2 years after surgery
Radiographic lumbar fusion status
The proportion of participants with radiographic evidence of nonunion (pseudarthrosis) based on standard radiographs and/or computed tomography (CT), as determined by the treating spine surgeon.
Time frame: 6 months, 1 year, and 2 years after surgery
Inpatient opioid consumption
Total opioid consumption during hospitalization, converted to morphine milligram equivalents (MME).
Time frame: During the index hospitalization (up to approximately 3 days)
Postoperative outpatient opioid consumption
Daily opioid use, reported as morphine milligram equivalents (MME), at routine postoperative follow-up visits.
Time frame: 2 weeks, 6 weeks, 6 months, 1 year, and 2 years after surgery
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